FDA
The product is a stainless steel stent mounted on a PTA balloon delivery device. The product is indicated for the palliation of malignant neoplasms in the biliary tree.
The product is labeled as Edwards Lifesciences, LifeStent LP SDS, Biliary Endoprosthesis. Manufactured by ORBUS, MEDICAL TECHNOLOGIES. 5363 NW 35th Ave, Fort Lauderdale, FL, 33309. Ph 954 730-071, www. orbus.com.
Distributed by: Edwards Lifesciences, Irvine, CA 82014-5888.
Ref. Baloon-Expandable Stent and delivery System.
Cata
BALLOONS HAVE LONGER THAN EXPECTED DEFLATION TIMES.
Orbus, the recalling firm issued a recall letter on March,19 2004 to their own label distributer, Edwards Lifesciences, requesting the return of unused product. Also Orbus provided the own label distributer with a sample sub-recall letter for them to send to users/hospital accounts. Sub-accounts were asked to return product to Edwards Lifesciences.